Our commitment to patients and researchers

Transparency and access to results of clinical studies are an ethical obligation that we as an industry take very seriously. On 1st January 2014, EFPIA/PhRMA published their Principles for Responsible Clinical Trial Data Sharing which demonstrates the innovative industry’s commitment to go even beyond the legal requirements of the clinical trial data sharing in both the European and US based member companies.

Since then, a lot has happened in the transparency environment for clinical trials, for example EMA has published in 2016 their Clinical Data Publication policy (formerly called Policy 70) and we anticipate the EU Clinical Trials Regulation 536/2014 to finally come into application by the end of January 2022 while increasing significantly the transparency requirements for pharmaceutical companies. The COVID-19 pandemic has underlined the need to publish the results of clinical trials in order to maintain public trust and healthcare professional’s ability to assess the newest scientific evidence in a timely manner.

In the meantime, and in order to assess the implementation of the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing among member companies, EFPIA conducted a survey of the compliance among member companies during July-September 2020. This followed the survey that was already conducted in 2016 and underlines the importance and dedication by EFPIA trade association to carefully monitor the progress on industry-led initiatives. These are not put in place for nothing and are in fact part of the requirements for each EFPIA member to adhere to on a continuous basis. All companies who had at least been a member of EFPIA for one year were asked to respond to the survey. Through this survey the members were also requested to provide information on additional transparency measures they are taking.

The Principles focus on sharing of results once products have obtained regulatory approval for being marketed in the EU and US. The scope therefore related to 35 EFPIA member companies (with at least one year of membership), out of which 33 (94%) responded to the survey.

The following 5 aspects were investigated:

1. Enhancing data sharing with researchers
2. Enhancing public access to clinical study information- CSR synopsis availability
3. Sharing results with patients who participate in clinical trials
4. Certifying procedures for sharing clinical trial information
5. Reaffirming commitments to publish clinical trial results.

Conclusions:

• The compliance rates to the 5 EFPIA-PhRMA principles were generally high but not ideal as they did not reach 100% for all items
• Challenges with the implementation of the principles were seen in specific process demands in regard to data sharing (eg. the current principles do not reflect the current use of multi-sponsor platforms)
• A large proportion of companies report disclosure and data sharing activities that go beyond the commitments, such as providing lay summaries to trial participants and/or the general public
• The principles should reflect the current regulatory registries approach to sharing results of clinical trials (e.g structured results tables, however the principles require sharing of a synopsis document)
• 100% compliance with the legal requirements of ClinicalTrials.gov and EU Clinical Trials registries was reported by members

EFPIA and our member companies are committed to responsible clinical data sharing and we look forward to continue engaging with the stakeholders to ensure clinical trial transparency while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.

Grateful acknowledgement is made for designing the survey questions and analysis of the results in an anonymised way by Merete Jørgensen, Senior Director Clinical Transparency, Novo Nordisk and Thomas Schindler, Boehringer Ingelheim Pharma GmbH & Co. KG, Clinical Operations Corporate. Both are members of the EFPIA Clinical Research Expert Group (CREG) and EFPIA Clinical Data Transparency pillar.